Improved levonorgestrel intrauterine slow release device and delivery device

Abstract

The utility model relates to an improved levonorgestrel intrauterine sustained release device and a delivery device. The improved levonorgestrel intrauterine sustained release device comprises a medicine carrying tube, a first soft wing, a second soft wing, a silk thread and a tail silk thread, the medicine carrying tube is a hollow tube with an interlayer, levonorgestrel is stored in the interlayer, and a through hole is formed in the middle of the medicine carrying tube; the starting ends of the first soft fin and the second soft fin are connected to the upper end part of the medicine carrying tube, and a gap is formed between the starting end of the first soft fin and the starting end of the second soft fin; one end of the silk thread is located in the through hole of the medicine carrying tube and contained in the through hole in a spiral spring shape, and the other end of the silk thread extends out of the medicine carrying tube along the through hole and the gap and forms a thread knot at the tail end. The tail wire is connected to the lower end of the medicine carrying tube or in the through hole of the medicine carrying tube, and the tail wire extends in the direction away from the upper end of the medicine carrying tube. According to the levonorgestrel intrauterine sustained-release device, the advantages of the Ginettone ring and the Munyule ring are combined in the fixing mode, double fixing can be achieved through the soft wings and the wire knots, and the sustained-release device is prevented from falling off.

Description

Technical Field

[0001] The utility model relates to a levonorgestrel intrauterine sustained-release device, in particular to an improved levonorgestrel intrauterine sustained-release device and a delivery device. Background Art

[0002] At present, there are two main structures of gynecological contraceptive rings. One is the Mirena ring (such as Figure 1 ), the other is the Gini ring (such as Figure 2 The two types of IUDs have different structures, fixing methods and principles.

[0003] like Figure 1 As shown, the Mirena ring includes a drug-carrying tube 1 and a pair of soft wings 2 arranged at the front end of the drug-carrying tube, which form a T-shape with the drug-carrying tube 1 and are placed in the uterine cavity near the uterine fundus. The soft wings 1 extend left and right to prevent the drug-carrying tube 1 from falling off from the uterus. The drug-carrying tube 1 is filled with a sustained-release progestin levonorgestrel, which releases about 20 micrograms of levonorgestrel every day. This release process can last for many years and is used to inhibit endometrial hyperplasia, contraception, and treat menorrhagia, adenomyosis, etc. The tail thread 3 is connected to the tail end of the drug-carrying tube, and the tail thread 3 extends out of the cervical os to facilitate the removal and replacement of the Mirena ring at a later stage.

[0004] like Figure 2 As shown, the Gini ring includes a plastic thread 11 and six copper rings 12 threaded on the plastic thread 11. The position of the copper ring 12 relative to the plastic thread 11 is fixed, and the inside of the copper ring 12 is hollow for inserting an iron needle. A knot 111 is provided at the front end of the plastic thread 11, and the tip of the iron needle is L-shaped, which can be inserted into the knot 111, and inserted into the uterine muscle bottom 0.5-1cm depth under the push of the iron needle. After the iron needle is retracted, the knot 111 is fixed in the uterine muscle bottom, and the Gini ring is suspended in the uterus in this way. The tail of the Gini ring is connected to the tail wire 13, and the tail wire 13 extends out of the cervical opening to facilitate later placement. The Gini ring contains copper elements, and copper ions are slowly released in the uterine cavity. Copper ions have multiple effects such as killing sperm, interfering with the fertilization process, and reducing the thickness of the endometrium.

[0005] However, the above two types of IUDs still have some shortcomings in clinical use. After the Mirena ring is unfolded into a T shape, its width is 32mm, but the uterus size varies from person to person. After the Mirena ring is installed in the uterus, some users with larger uteruses are prone to the problem of it falling off. The Gini ring is fixed to the uterine muscle layer at a depth of 0.5-1cm with a knot, and the ring is firmly installed, but the copper IUD can cause a mild, persistent non-infectious inflammatory reaction in the uterine cavity. Some users may experience lumbar pain and other problems after the ring is placed. Utility Model Content

[0006] 1. Technical issues to be resolved

[0007] In view of the above-mentioned shortcomings and deficiencies of the prior art, the utility model provides an improved levonorgestrel intrauterine sustained-release device and delivery device, which combines the advantages of the Mirena ring and the Generic ring, and achieves that the ring is firmly installed, is not easy to fall off, and will not cause problems such as lumbar pain.

[0008] (II) Technical solution

[0009] In a first aspect, the utility model provides an improved levonorgestrel intrauterine sustained-release device, which comprises: a drug-carrying tube, a first soft wing, a second soft wing, a silk thread and a tail thread;

[0010] The drug-carrying tube is a hollow tube with an interlayer, in which the sustained-release levonorgestrel is stored, and a through hole is provided in the middle of the drug-carrying tube; the starting ends of the first soft wing and the second soft wing are connected to the upper end of the drug-carrying tube, and there is a gap between the starting ends of the first soft wing and the starting ends of the second soft wing, and the gap is connected to the through hole in the middle of the drug-carrying tube;

[0011] One end of the wire is located in the through hole of the drug-carrying tube and the wire is received in the through hole in the shape of a spiral spring, and the other end of the wire extends along the through hole and the gap to the outside of the drug-carrying tube and forms a knot at the end; the tail wire is connected to the lower end of the drug-carrying tube or the through hole of the drug-carrying tube, and the tail wire extends in a direction away from the upper end of the drug-carrying tube.

[0012] According to a preferred embodiment of the utility model, the silk thread is a 00-gauge polypropylene surgical thread; the tail thread is a polyethylene surgical thread with a diameter of 0.19 mm. The silk thread has a certain hardness and thickness, is more durable, forms a larger knot, and can be more firmly implanted in the uterine muscle layer to achieve fixation. Compared with the silk thread, the tail thread is more slender and soft, and there is no discomfort when it is retained in the body.

[0013] According to a preferred embodiment of the utility model, it also includes a wire fixing part, which is sleeved in the through hole of the drug-carrying tube. The wire fixing part is a small tube with a threaded groove on the outer wall. The small tube cannot fall off from both ends of the through hole and can rotate in the through hole. A tube hole coaxial with the through hole is provided in the middle of the small tube. One end of the wire located in the through hole of the drug-carrying tube is wound in the threaded groove on the outside of the tube and the end is fixed to the wire fixing part.

[0014] According to a preferred embodiment of the utility model, the interior of the through hole is narrowed at both ends and wider in the middle.

[0015] In a second aspect, the utility model also relates to a delivery device for installing the improved levonorgestrel intrauterine sustained-release device, which comprises: a hollow long guide tube, a handle, an operating block and a steel needle;

[0016] The outer wall of the upper end of the hollow long guide tube is provided with a length scale and a marking block, and the marking block can be operated to slide up and down or be fixed along the hollow long guide tube;

[0017] The lower end of the hollow long guide tube is connected to a handle, and the handle is provided with a sleeve hole, and the lower end of the hollow long guide tube is inserted into the sleeve hole; an operation window is provided on the handle, and the normal line of the operation window is perpendicular to the center line of the sleeve hole; slide grooves are provided on the left and right side walls of the operation window, and the extension direction of the slide grooves is parallel to the center line of the sleeve hole; the two ends of the operation block cooperate with the slide grooves so that the operation block can move up and down in the operation window; the operation block is connected to the lower end of the hollow long guide tube;

[0018] The improved levonorgestrel intrauterine sustained-release device is placed as a whole inside the hollow long guide tube;

[0019] The steel needle is arranged inside the hollow long guide tube, the lower end of the steel needle is fixed to the handle, and the upper end is the needle tip. The needle tip penetrates from the bottom of the drug-carrying tube of the improved levonorgestrel intrauterine sustained-release device, passes out from the top and is inserted into the knot of the silk thread; the needle tip of the steel needle does not extend to the outside of the hollow long guide tube.

[0020] (III) Beneficial effects

[0021] The levonorgestrel intrauterine sustained-release device of the utility model combines the advantages of the Gini ring and the Mirena ring in terms of fixing methods, using soft wings to achieve single-layer fixation, and using a thread knot in the uterine muscle base to achieve double fixation to prevent the sustained-release device from falling off. The drug-carrying tube is set as a hollow tube with an interlayer, and the sustained-release levonorgestrel is stored in the interlayer. The sustained-release levonorgestrel is used to achieve contraception, treatment of menorrhagia, adenomyosis and other effects. Compared with the Gini ring, it has the effect of preventing the inflammatory reaction and lumbosacral pain caused by the copper IUD in the uterine cavity. Furthermore, the utility model also provides a delivery device adapted to and matched with the retarder, and there is no need to replace the delivery tool when placing the slow-release device in the uterine cavity, which is simple to operate and reduces the discomfort of the user. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is the structure of the Mirena ring in the prior art.

[0023] Figure 2 It is the structure of a Gini ring in the prior art.

[0024] Figure 3 It is a schematic diagram of the improved levonorgestrel intrauterine sustained-releasing device of the utility model.

[0025] Figure 4 It is a schematic diagram of the silk thread fixing part in the improved levonorgestrel intrauterine sustained-release device of the utility model.

[0026] Figure 5 The utility model is a schematic structural diagram of a delivery device for installing an improved levonorgestrel intrauterine sustained-release device. DETAILED DESCRIPTION

[0027] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below through specific implementation modes in conjunction with the accompanying drawings.

[0028] Example 1

[0029] like Figure 3 As shown in FIG. 1 , the improved levonorgestrel intrauterine sustained-release device of the preferred embodiment of the utility model comprises a drug-carrying tube 10, a first soft wing 21, a second soft wing 22, a silk thread 30 and a tail silk thread 40. Figure 3 As shown, the drug-carrying tube 10 is a hollow tube with an interlayer, and the inner space of the interlayer is used to store the sustained-release levonorgestrel. A through hole 101 is provided in the middle of the drug-carrying tube 10. The starting ends of the first soft wing 21 and the second soft wing 22 are connected to the upper end of the drug-carrying tube 10 and do not block the upper opening of the through hole 101. The inside of the through hole 101 is narrowed at both ends and wide in the middle. There is a gap P between the starting ends of the first soft wing 21 and the second soft wing 22, and the gap P is connected to the through hole 101 of the drug-carrying tube 10. One end of the silk thread 30 is located in the through hole 101 of the drug-carrying tube 10 and most of the silk thread is received in the through hole 101 in the shape of a spiral spring. The other end of the silk thread 30 extends along the through hole 101 and the gap P to the outside of the drug-carrying tube 10 and forms a knot 301 at the end, which is used to combine with the tip of the steel needle, and the knot 301 is inserted into the bottom layer of the uterine muscle to a depth of 0.5-1 cm using the steel needle. A tail wire 40 is connected to the lower end of the drug-carrying tube 10, and the tail wire 40 extends in a direction away from the upper end of the drug-carrying tube 10. The tail wire 40 is used to be placed outside the cervical os, so as to facilitate the removal and replacement of the entire slow-release device. Among them, the silk thread 30 is a No. 00 polypropylene surgical thread, and the tail wire 40 is a polyethylene surgical thread with a diameter of 0.19 mm. The silk thread 30 adopts a thicker and harder No. 00 polypropylene surgical thread, which is more durable, has a larger knot, and can be more firmly implanted in the uterine muscle layer to achieve fixation. The tail wire 40 uses a softer and thinner thread to reduce the discomfort of the user who places the slow-release device.

[0030] Since a steel needle is required to insert the thread knot 301 into the bottom layer of the uterine muscle, a steel needle is inserted into the through hole 101. The steel needle is inserted upward from the lower end of the drug-carrying tube 10 and combined with the thread knot 301. In order to prevent the silk thread 30 from being pushed to the outside of the drug-carrying tube 10 during the insertion of the steel needle, the silk thread 30 should be stored inside the through hole 101 of the drug-carrying tube 10 to ensure that it does not block the through hole 101, that is, to allow the steel needle to pass through. For this purpose, see Figure 4As shown, a wire fixing member 50 is installed in the through hole 101. The wire fixing member 50 is a small tube member with a thread groove on the outer wall. The inside of the through hole 101 is narrowed at both ends and wide in the middle. The wire fixing member 50 cannot be disengaged from the upper end or the lower end of the through hole 101. A tube hole coaxial with the through hole 101 is provided in the middle of the wire fixing member 50, and the tube hole can be used for the steel needle to pass through. The main part of the wire 30 is wound in the thread groove on the outer wall of the wire fixing member to achieve the function of straightening the wire, and at the same time, the end of the wire 30 (the end opposite to the knot 301) is fixed on the wire fixing member 50. When the steel needle passes upward from the lower end of the drug-carrying tube 10, the steel needle passes through the middle of the wire fixing member 50, and finally passes through the gap between the upper end of the drug-carrying tube 10 and the two soft wings, and is combined with the knot 301 pre-set on the outside of the drug-carrying tube 10. By pushing forward, the wire fixing member 50 is caused to rotate and release the wire 30 stored therein, so that the wire 30 reaches a predetermined length.

[0031] The levonorgestrel intrauterine sustained-release device of the utility model combines the advantages of the Gini ring and the Mirena ring in terms of placement, uses soft wings to achieve primary fixation, and uses a thread knot in the uterine muscle base to achieve secondary fixation to prevent the sustained-release device from falling off. The drug-carrying tube is a hollow tube with an interlayer, and the sustained-release levonorgestrel is stored in the interlayer. The sustained-release levonorgestrel achieves the effects of contraception, treatment of menorrhagia, adenomyosis, etc., and compared with the Gini ring, it can prevent the inflammatory reaction caused by the copper IUD in the uterine cavity and the symptoms of lumbar pain, etc.

[0032] Example 2

[0033] In order to achieve the delivery and installation of the improved levonorgestrel intrauterine sustained-release device in Example 1, as Figure 5 As shown, the utility model also provides a matching delivery device, which includes a hollow long guide tube 60, a handle 70, an operating block 80 and a steel needle 90.

[0034] The improved levonorgestrel intrauterine sustained-release device is placed as a whole inside the upper end of the hollow long guide tube 60, including the drug-carrying tube 10 and the first soft wing 21, the second soft wing 22, etc., which are all bound inside the upper end of the hollow long guide tube 60, and the tail wire 40 is inside the hollow long guide tube 60 and passes downward. The first soft wing 21 and the second soft wing 22 are pre-shaped elastic and soft plastic structures. When bound by the hollow long guide tube 60, the first soft wing 21 and the second soft wing 22 are close to each other and extend upward but do not exceed the upper end opening of the hollow long guide tube 60.

[0035] The outer wall of the upper end of the hollow long guide tube 60 is provided with a length scale and a marking block 601. The marking block 601 can be operated by a person to slide along the hollow long guide tube 60 to a predetermined position. After being released, the marking block 601 stays at the predetermined position. The role of the length scale and the marking block 601 is: when installing the levonorgestrel intrauterine sustained-release device, the depth of the user's uterus is measured in advance using a probe, and the marking block 601 is moved to the corresponding scale according to the depth. When the doctor operates later, the relative position of the front end of the hollow long guide tube 60 to the uterus can be grasped according to the position of the marking block.

[0036] A handle 70 is connected to the lower end of the hollow long guide tube 60, and the handle 70 is provided with a sleeve hole. The lower end of the hollow long guide tube 60 is inserted into the sleeve hole to achieve a movable combination with the handle 70. An operation window 701 is provided on the handle 70, and the normal line of the operation window 701 is perpendicular to the center line of the sleeve hole. Slide grooves are provided on the left and right side walls of the operation window 701, and the extension direction of the slide grooves is parallel to the center line of the sleeve hole. The slide grooves are used for the operation block 80 to be combined. The two ends of the operation block 80 cooperate with the slide grooves, and the operation block 80 can be moved up and down along the handle by pressing and sliding the thumb up and down. The operation block 80 is connected to the lower end of the hollow long guide tube 60. When the operation block 80 slides downward, the hollow long guide tube 60 can be pulled downward, and the improved levonorgestrel intrauterine sustained-release device located in the hollow long guide tube 60 is exposed.

[0037] The steel needle 90 is also inserted into the hollow long guide tube 60. The lower end of the steel needle 90 is fixed to the lower end of the handle. The upper end of the steel needle 90 is an L-shaped needle tip. The needle tip enters from the bottom of the drug-carrying tube 10 and exits from the top and is plugged into the knot 301 of the silk thread 30. However, before use, the needle tip of the steel needle 90 does not extend to the outside of the hollow long guide tube 60. At this time, the tip of the steel needle 90 is clamped between the first soft wing 21 and the second soft wing 22 at the upper end of the improved levonorgestrel intrauterine sustained-release device.

[0038] When placing the slow-release device, according to the pre-detected uterine depth, the marking block 601 is moved to the corresponding position as a mark. Then, the handle 70 is held, and the hollow long guide tube 60 is extended into the uterine cavity. After reaching the bottom of the uterine cavity, the handle 70 is held and the whole body is retreated about 1 cm. While keeping the handle 70 in place, the operation block 80 is pressed to slide downward, driving the hollow long guide tube 60 to be pulled downward to expose the front end of the improved levonorgestrel intrauterine slow-release device. At this time, the first soft wing 21 and the second soft wing 22 are freed from restraint, and they are respectively unfolded to the left and right directions to form a T-shape with the drug-carrying tube 10. At this time, the tip of the steel needle 90 between the first soft wing 21 and the second soft wing 22 and the knot 301 combined therewith are exposed. The handle 70 is held to push the delivery device forward about 1.5 cm, and the tip of the steel needle 90 is inserted into the bottom layer of the uterine muscle by about 0.5 cm. Then, the handle 70 is held to retract the delivery device as a whole, so that the knot 301 is retained in the bottom layer of the uterine muscle. While keeping the handle 70 in place, the operating block 80 is pressed to make it continue to slide downward, driving the hollow long guide tube 60 to be pulled downward, so as to expose the improved levonorgestrel intrauterine sustained-release device as a whole, and the drug-carrying tube 10 is completely transferred from the hollow long guide tube 60 to the uterine cavity. Finally, after the hollow long guide tube 60 is withdrawn from the uterine cavity as a whole, the tail thread is cut off from the cervical opening, and the placement process of the improved levonorgestrel intrauterine sustained-release device is completed. The delivery device of the utility model does not need to replace the delivery tool when placing the sustained-release device in the uterine cavity, and the operation is simple and fast, reducing the discomfort of the user.

[0039] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A modified levonorgestrel intrauterine sustained-release device, characterized in that: It includes: A drug-carrying tube, a first soft wing, a second soft wing, a silk thread and a tail silk thread; The drug-carrying tube is a hollow tube with an interlayer, in which levonorgestrel is stored, and a through hole is provided in the middle of the drug-carrying tube; the starting ends of the first soft wing and the second soft wing are connected to the upper end of the drug-carrying tube, and there is a gap between the starting ends of the first soft wing and the second soft wing, and the gap is connected to the through hole in the middle of the drug-carrying tube; One end of the wire is located in the through hole of the drug-carrying tube and the wire is received in the through hole in the shape of a spiral spring, and the other end of the wire extends along the through hole and the gap to the outside of the drug-carrying tube and forms a knot at the end; the tail wire is connected to the lower end of the drug-carrying tube or the through hole of the drug-carrying tube, and the tail wire extends in a direction away from the upper end of the drug-carrying tube.

2. The improved levonorgestrel intrauterine sustained-release device according to claim 1, characterized in that: The silk thread is a No. 00 polypropylene surgical thread; the tail thread is a polyethylene surgical thread with a diameter of 0.19 mm.

3. The improved levonorgestrel intrauterine sustained-release device according to claim 1 or 2, characterized in that: It also includes a wire fixing part, which is sleeved in the through hole of the drug-carrying tube. The wire fixing part is a small tube with a threaded groove on the outer wall. The small tube cannot fall off from both ends of the through hole and can rotate in the through hole. A tube hole coaxial with the through hole is provided in the middle of the small tube. One end of the wire located in the through hole of the drug-carrying tube is wound in the threaded groove on the outside of the tube and the end is fixed to the wire fixing part.

4. The improved levonorgestrel intrauterine sustained-release device according to claim 3, characterized in that: The interior of the through hole is narrowed at both ends and widened in the middle.

5. A delivery device for installing the improved levonorgestrel intrauterine sustained-release device according to any one of claims 1 to 4, characterized in that: It comprises: a hollow long guide tube, a handle, an operating block and a steel needle; the upper end outer wall of the hollow long guide tube is provided with a length scale and a marking block, and the marking block can be operated to slide up and down or be fixed along the hollow long guide tube; The lower end of the hollow long guide tube is connected to a handle, and the handle is provided with a sleeve hole, and the lower end of the hollow long guide tube is inserted into the sleeve hole; an operation window is provided on the handle, and the normal line of the operation window is perpendicular to the center line of the sleeve hole; slide grooves are provided on the left and right side walls of the operation window, and the extension direction of the slide grooves is parallel to the center line of the sleeve hole; the two ends of the operation block cooperate with the slide grooves so that the operation block can move up and down in the operation window; the operation block is connected to the lower end of the hollow long guide tube; The improved levonorgestrel intrauterine sustained-release device is placed as a whole inside the hollow long guide tube; the steel needle is arranged inside the hollow long guide tube, the lower end of the steel needle is fixed to the handle, and the upper end is the needle tip, the needle tip penetrates from the bottom of the drug-loading tube of the improved levonorgestrel intrauterine sustained-release device, passes out from the top and is inserted into the knot of the silk thread; the needle tip of the steel needle does not extend to the outside of the hollow long guide tube.

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